Quality Systems - Quality System Investigator
Witt/Kieffer, Lakewood, NJ, United States
EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.
Basic Job Functions
This position will be responsible for conducting thorough investigations into manufacturing deviations, non-conformances, and other quality issues, ensuring all investigations are conducted in accordance with current Good Manufacturing Practices (cGMP) regulations, aiming to identify root causes, propose corrective actions, and prevent recurrence of problems while maintaining compliance with regulatory standards.
This position will collaborate with internal Subject Matter Experts (e.g. Analytical, Manufacturing, Packaging and Quality and IT personnel). Additionally, this role will work with customers to ensure timely reporting of Quality incidents and customer concurrence with audit findings and Corrective and Preventive Actions (CAPAs). This role requires strong computer skills as well as problem solving skills.
Essential Functions of the Job
Lead investigations into Quality Events and customer complaints
Perform root cause analysis using industry standards, such as 5Whys and Fishbone diagrams
Determine relevant corrective and preventative action
Perform risk assessment to determine safety and efficacy of product
Oversee timely completion of deviations, CAPAs, investigations, complaints
Track and trend events/deviations
Provide communication plans for ongoing deviations and CAPAs
Maintain compliance with company policies, regulatory requirements, quality specifications, safety standards and sanitation practices
Proactively raise quality related risks, issues, and opportunities.
Support the organization in maintaining a work environment focused on quality, respect, open communication, collaboration, integration, and teamwork.
Other duties as assigned.
Minimum Requirements of the Job
Must have knowledge of basic principles, theories and laws, and policies and procedures that pertain to investigations.
Conduct interviews with subject matter experts
Strong technical writing skills
Able to quickly and accurately type and enter data
Attention to detail
Excellent communication and organizational skills
Flexibility to adjust to changing priorities.
Physical Requirements
Ability to sit for long periods of time.
Supervisory Responsibilities
No
Travel
None
Education
Must have a bachelor’s degree and experience conducting investigations in a cGMP environment. Experience with process investigations and writing CAPAs preferred.
Full-Time/Part-Time Full-Time
Shift -not applicable-
Position Quality System Investigator
Location Lakewood
This position is currently accepting applications.
#J-18808-Ljbffr
Basic Job Functions
This position will be responsible for conducting thorough investigations into manufacturing deviations, non-conformances, and other quality issues, ensuring all investigations are conducted in accordance with current Good Manufacturing Practices (cGMP) regulations, aiming to identify root causes, propose corrective actions, and prevent recurrence of problems while maintaining compliance with regulatory standards.
This position will collaborate with internal Subject Matter Experts (e.g. Analytical, Manufacturing, Packaging and Quality and IT personnel). Additionally, this role will work with customers to ensure timely reporting of Quality incidents and customer concurrence with audit findings and Corrective and Preventive Actions (CAPAs). This role requires strong computer skills as well as problem solving skills.
Essential Functions of the Job
Lead investigations into Quality Events and customer complaints
Perform root cause analysis using industry standards, such as 5Whys and Fishbone diagrams
Determine relevant corrective and preventative action
Perform risk assessment to determine safety and efficacy of product
Oversee timely completion of deviations, CAPAs, investigations, complaints
Track and trend events/deviations
Provide communication plans for ongoing deviations and CAPAs
Maintain compliance with company policies, regulatory requirements, quality specifications, safety standards and sanitation practices
Proactively raise quality related risks, issues, and opportunities.
Support the organization in maintaining a work environment focused on quality, respect, open communication, collaboration, integration, and teamwork.
Other duties as assigned.
Minimum Requirements of the Job
Must have knowledge of basic principles, theories and laws, and policies and procedures that pertain to investigations.
Conduct interviews with subject matter experts
Strong technical writing skills
Able to quickly and accurately type and enter data
Attention to detail
Excellent communication and organizational skills
Flexibility to adjust to changing priorities.
Physical Requirements
Ability to sit for long periods of time.
Supervisory Responsibilities
No
Travel
None
Education
Must have a bachelor’s degree and experience conducting investigations in a cGMP environment. Experience with process investigations and writing CAPAs preferred.
Full-Time/Part-Time Full-Time
Shift -not applicable-
Position Quality System Investigator
Location Lakewood
This position is currently accepting applications.
#J-18808-Ljbffr